Seeing Sepsis with New Eyes How a new PCT assay is bringing critical insights to light.

How fast can we find better ways to win the fight against sepsis? For hospitals, healthcare professionals and patients across the country, that answer can’t come soon enough. Consider this: In the five or so minutes it will take an average reader to finish this article,1 more than two people will die from sepsis in the United States. That’s one person every two minutes.2

More people die from sepsis than from prostate cancer, breast cancer and AIDS combined.3 In addition to the human loss, the financial costs are staggering. Sepsis is the No.1 financial burden for hospitals, with $24 billion spent every year.4

More people die from sepsis than from prostate cancer,
breast cancer and AIDS combined.3

With sepsis, clinicians are fighting a battle on multiple fronts. First, there’s the time factor. Every hour treatment is delayed, survival rates can decrease by 7.6 percent.5 In addition, the diagnosis of sepsis can be a challenge due to its ambiguous signs and symptoms. Even after a definitive diagnosis of sepsis, treatment is a tightrope walk that involves fine-tuning the prescription of antibiotics so not too much, or too little, is administered.

PCT: A powerful ally delivers fresh insight

It’s a complex, high-stakes battle. However, hospitals have found a highly effective ally as they combat this stealthy, stalwart syndrome. Procalcitonin (PCT) is a sensitive and specific biomarker associated with the inflammatory response to bacterial infection, and it can provide valuable insights when combined with clinical judgment.6

“There are many unique factors about PCT,” says the Director of Pharmacy and Laboratory Services at Five Rivers Medical Center Mike Broyles, PharmD. “Of the more than 175 biomarkers available to assess infection today, PCT is the only one that requires both bacterial toxins and inflammatory response in order for levels to be elevated. This is the mechanism that provides its specificity to bacterial, and not viral, infections.”

For more than a decade, clinicians outside of the United States have had access to operationally efficient PCT platforms, enabling them to cost-effectively leverage PCT to improve the outcomes of patients with sepsis. It wasn’t until 2016 that PCT cleared the automation hurdle in the United States.7 Now, due to the recent FDA clearance of PCT on a fully automated and integrated platform from Roche Diagnostics, many more U.S. hospitals have started integrating PCT into their sepsis protocol.

However, hospitals vary in whether their sepsis protocols stop after complying with SEP-1,8 or if their sepsis protocols take further, more proactive steps. Here’s a look at how three institutions have leveraged PCT to uncover critical, and previously invisible, sepsis insights.

Improving patient care in a busy emergency department

Across the UC San Diego Health system, the emergency departments see more than 130,000 patients annually.9

“We’re kind of the front doors of the hospital,” says Associate Clinical Professor of Emergency Medicine Sean-Xavier Neath, M.D., Ph.D. “The decisions we make and the tests we use serve as baselines for what people in the hospital and in clinical settings will do.”

At UC San Diego Health, Dr. Neath and his colleagues, including Professor of Pathology, Director of Toxicology and Associate Director of Clinical Chemistry Robert L. Fitzgerald, Ph.D., had been “hankering” for a PCT solution for a while.

“We believe it’s a good marker,” Dr. Fitzgerald says. “For us, the limitation had been that we didn’t have an analyzer that could run a PCT in our highly automated lab.”

Previously, the assay was available only as a send-out at the hospital, which was not practical in terms of emergency department care, where time is of the essence in making treatment decisions.

“Turnaround time is key to me as an emergency physician,” Dr. Neath says.

When PCT became available on the Roche platform, Dr. Neath and Dr. Fitzgerald worked with a cross-disciplinary team, including PharmDs, cardiologists and clinicians from the hospital’s sepsis committee, to bring it to UC San Diego Health. The assay is still very new to the hospital, which started running it this past April, but already Dr. Neath sees its promise.

“From the emergency medicine side, some physicians may not feel they need PCT for sepsis management,” Dr. Neath says. “But I would tell them that the literature has shown the implications can be huge with regard to how long a patient stays in the hospital. PCT provides a baseline of how sick a patient was when he or she came in, and from that, it can help inform treatment choices to ensure the best outcome.”

In other words, because PCT is highly specific to bacterial infection, and its results correspond to the severity of the infection, emergency clinicians can act with a clearer prognostic picture of the patient.

“PCT provides a baseline of how sick a patient was when he or she came in,
and from that, it can help inform treatment choices to ensure the best outcome.”

Reducing antibiotics and patient stays at a regional hospital

While the clinicians at UC San Diego Health are just beginning to use a PCT assay, it’s a well-established practice at Washington Regional Medical Center. The 425-bed facility, located in Fayetteville, Ark., implemented the use of PCT in October 2012. In December 2016, the hospital switched its PCT testing to the Roche platform to take advantage of the labor-saving benefits of automation.

“We started using procalcitonin due to its correlation to the severity of bacterial infection,” explains Washington Regional’s Infectious Disease Specialist and Antibiotic Stewardship Director James Newton, M.D. “As we became more experienced with interpreting the test, we began to realize the full breadth of PCT’s clinical utilities, and how it can support our clinicians in making more targeted treatment decisions.”

About a year after clinicians began using PCT, Washington Regional started a sepsis management program due to a higher-than-expected mortality rate. However, the mortality rate decreased dramatically once the sepsis management program using PCT was in place, dropping from about 29 percent in 2012 to roughly 11 percent in 2015.

At Washington Regional, PCT plays a key role in treating sepsis once it’s been diagnosed. As Dr. Newton explains, if a patient comes into the hospital’s emergency department presenting septic symptoms, a triage nurse takes vital signs. If the vital signs meet two of the four criteria for systemic inflammatory response syndrome (SIRS), the nurse immediately orders a lactate. If the lactate results are higher than a 2, the nurse has the emergency physician take over, and the CMS SEP-1 protocol is initiated. After the initial wave of SEP-1 guided treatment, the hospital uses PCT to help determine the patient’s prognosis.

“In our institution, we have found that when we use PCT guidance for sepsis and antibiotic treatment decisions, we see that we’re better stewards of antibiotics,” Dr. Newton says. “What’s more, it’s an affordable test. If I can get a patient out of the ICU a day or two earlier, I’m saving a significant amount of money.”

“If I can get a patient out of the ICU a day or two earlier,
I’m saving a significant amount of money.”

For Dr. Broyles, providing the right treatment to the right patient for the right duration has always been a priority at Five Rivers Medical Center. So, when the PCT assay was first released about seven years ago, Dr. Broyles made sure it was brought on board at the 50-bed hospital, located in Pocahontas, Ark. At Five Rivers, the assay is used as a measurement tool for bacterial load that has shown it enables clinicians to act much more quickly and proactively.

“Since we brought on procalcitonin, the number of patients that would have gone to the ICU is down 50 percent,” Dr. Broyles says.

For Dr. Broyles, precision is a key factor when running a PCT test.

“To know what’s normal, you have to be able to measure below where clinically relevant bacterial infections are present,” Dr. Broyles explains. “A lot of literature says that’s below 0.1ng/mL. If your test doesn’t go down low enough and produce a precise result, that’s a problem.”

Introducing the PCT assay has worked so well for Five Rivers that a recent in-house study of 2,152 patients has revealed impressive results.

“We saw a 47.1 percent reduction in antimicrobial days of therapy, a 51.5 percent reduction in sepsis mortality and a 37.3 percent reduction in 30-day readmissions,” Dr. Broyles says. “PCT has absolutely made a significant difference in improving patient outcomes.”

“We saw a 47.1 percent reduction in antimicrobial days of therapy, a 51.5 percent reduction in sepsis mortality and a 37.3 percent reduction in 30-day readmissions.”

PCT uncovers promising possibilities in the fight against sepsis

From crowded emergency departments in big cities to small community hospitals, clinicians and laboratorians alike are discovering the multiple benefits of implementing PCT as part of their sepsis protocols.

With its ability to detect and monitor the severity of bacterial infections and provide fast, reliable results, the newly approved Elecsys® BRAHMS PCT on Roche Diagnostics’ automated platform is revealing new possibilities in winning the fight against sepsis: dramatic improvements in patient outcomes where they are so desperately needed.

About the performance of the Elecsys BRAHMS PCT assay

The Elecsys BRAHMS PCT assay is enabled by the fully automated and integrated cobas® analyzers, which require no reagent preparation or hands-on testing. It offers clinicians access to rapid results with a short incubation time of only 18 minutes and has a broad measuring range. Delivering industry-leading precision of <7 percent CV at 0.07ng/mL, the assay’s ability to precisely detect low levels of PCT is especially important to accurately detect PCT in healthy individuals and in individuals requiring antibiotic treatment.